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FDA 510(k)

GI Genius

K-Number: K211951 · 2021-07-23

Decision Date2021-07-23
Product CodeQNP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GI Genius is the device name listed in this FDA 510(k) record. The listed applicant is Cosmo Artificial Intelligence - Ai, Ltd.. It received FDA 510(k) clearance on 2021-07-23 under 510(k) number K211951. The device is classified under product code QNP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GI Genius?

GI Genius is a medical device that received FDA 510(k) clearance on 2021-07-23. The listed applicant is Cosmo Artificial Intelligence - Ai, Ltd.. The 510(k) number is K211951.

When did GI Genius receive FDA 510(k) clearance?

GI Genius received FDA 510(k) clearance on 2021-07-23, under 510(k) number K211951.

Who is the listed applicant for GI Genius?

The FDA 510(k) record lists Cosmo Artificial Intelligence - Ai, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GI Genius?

The FDA product code for GI Genius is QNP.

Other records listing Cosmo Artificial Intelligence - Ai, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: QNP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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